title: "Pre-schoolers in the playground" an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial.
abstract: BACKGROUND
  The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0-5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old ("Pre-schoolers in the Playground"; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents.
  
  
  METHODS
  One hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These include physical activity via triaxial, accelerometry (Actigraph GT3X+), anthropometry (height, body mass, BMI, waist and upper arm circumference), health related quality of life for child (PedsQL) and parent (EQ5D), parent wellbeing (ComQol-A5), injuries and health service use. A health economic evaluation will also be undertaken.
  
  
  CONCLUSIONS
  It is anticipated that results of this pilot trial will be published in spring 2015.
  
  
  BACKGROUND
  Current controlled trials: ISRCTN54165860.
authors.affiliation: Born in Bradford Cohort Study, Bradford Institute for Health Research, Bradford, UK. sally.barber@bthft.nhs.uk.
authors.forename: Sally E
authors.initials: SE
authors.lastname: Barber
authors.forename: Cath
authors.initials: C
authors.lastname: Jackson
authors.forename: Shaheen
authors.initials: S
authors.lastname: Akhtar
authors.forename: Daniel D
authors.initials: DD
authors.lastname: Bingham
authors.forename: Hannah
authors.initials: H
authors.lastname: Ainsworth
authors.forename: Catherine
authors.initials: C
authors.lastname: Hewitt
authors.forename: Gerry
authors.initials: G
authors.lastname: Richardson
authors.forename: Carolyn D
authors.initials: CD
authors.lastname: Summerbell
authors.forename: Kate E
authors.initials: KE
authors.lastname: Pickett
authors.forename: Helen J
authors.initials: HJ
authors.lastname: Moore
authors.forename: Ash C
authors.initials: AC
authors.lastname: Routen
authors.forename: Claire L
authors.initials: CL
authors.lastname: O'Malley
authors.forename: Shirley
authors.initials: S
authors.lastname: Brierley
authors.forename: John
authors.initials: J
authors.lastname: Wright
mesh_terms: D056044:Actigraphy; D000886:Anthropometry; D002652:Child Behavior; D002675:Child, Preschool; D015928:Cognitive Behavioral Therapy; D003362:Cost-Benefit Analysis; D004739:England; D005240:Feasibility Studies; D015438:Health Behavior; D017048:Health Care Costs; D006293:Health Promotion / Q000191:economics / Q000379:methods*; D006801:Humans; D007223:Infant; D008019:Life Style; D009043:Motor Activity; D010865:Pilot Projects; D010988:Play and Playthings; D012107:Research Design; D012574:Schools; D012919:Social Behavior; D011795:Surveys and Questionnaires; D013997:Time Factors